Streamlining Tech Transfer and Ensuring Compliance: Oakley's Partnership with a US Company in Selecting a European Contract Manufacturer for Sterile Pre-filled Syringes
Abstract:
This case study focuses on Oakley's collaboration with a US-based company, where Oakley was engaged to select a European contract manufacturer for a sterile, pre-filled syringe product. The project involved transferring the manufacturing process from an existing contract manufacturing organization (CMO) in Southeast Asia to the chosen European site. Oakley successfully planned and managed the tech transfer, ensuring the generation of necessary data for regulatory approval of the site transfer. Additionally, Oakley undertook a comprehensive compliance audit and inspection of the European manufacturing site. The study also highlights Oakley's negotiation expertise in managing the associated costs of transfer, validation, and ongoing commercial production.
Introduction:
The selection of a contract manufacturer plays a crucial role in the success of pharmaceutical product manufacturing. This case study explores Oakley's partnership with a US-based company, wherein Oakley was entrusted with the responsibility of choosing a European contract manufacturer for a sterile, pre-filled syringe product. Oakley's scope of work included overseeing the seamless tech transfer, ensuring compliance with regulatory requirements, conducting a comprehensive compliance audit, and negotiating the costs associated with transfer, validation, and ongoing commercial production.
Objective:
The primary objective of this case study is to showcase Oakley's involvement in assisting a US company in selecting a European contract manufacturer and facilitating a smooth tech transfer of the sterile, pre-filled syringe manufacturing process. The study emphasizes Oakley's capabilities in planning and managing tech transfer, ensuring regulatory compliance, conducting compliance audits, and negotiating cost-related aspects. It demonstrates Oakley's expertise in driving efficient and cost-effective manufacturing solutions for clients.
Methods:
This case study employs a qualitative approach, drawing insights from interviews conducted with key stakeholders from Oakley and the US-based client. Primary data sources include project managers, tech transfer specialists, compliance auditors, and company representatives involved in the collaboration. Secondary data sources consist of industry publications, regulatory guidelines, and relevant documentation related to tech transfer, compliance audits, and cost negotiations.
Results:
1. Selection of European Contract Manufacturer: Oakley collaborated closely with the US-based client to identify and select a European contract manufacturer that met the specific requirements for the sterile, pre-filled syringe product. This involved evaluating potential partners based on their expertise, capacity, quality systems, regulatory compliance, and commercial viability.
2. Seamless Tech Transfer Planning and Management: Oakley meticulously planned and managed the tech transfer process from the existing CMO in Southeast Asia to the chosen European site. They developed a comprehensive transfer strategy, including timelines, milestones, and resource allocation, to ensure a smooth transition. Oakley coordinated the transfer activities, overseeing the generation of necessary data for regulatory approval.
3. Regulatory Approval and Compliance: Oakley played a crucial role in ensuring that the appropriate data was generated to support regulatory approval for the site transfer. They worked closely with the European contract manufacturer to generate documentation related to process validation, stability studies, quality control data, and regulatory submissions. Oakley's expertise in compliance requirements and regulatory standards ensured a seamless approval process.
4. Comprehensive Compliance Audit and Inspection: As part of their scope, Oakley conducted a thorough compliance audit and inspection of the European manufacturing site. They assessed the site's adherence to Good Manufacturing Practices (GMP) and other relevant quality standards. Oakley identified areas for improvement, provided recommendations, and supported the implementation of corrective actions to enhance compliance and mitigate risks.
5. Cost Negotiations and Commercial Production: In addition to their technical responsibilities, Oakley also handled the negotiation of costs associated with tech transfer, validation, and ongoing commercial production. Their expertise in financial management and contract negotiations ensured optimal cost agreements, enabling the client to establish a viable and sustainable manufacturing partnership.
Conclusion:
Oakley's collaboration with the US-based company in selecting a European contract manufacturer for sterile, pre-filled syringes exemplifies their expertise in seamless tech transfer, regulatory compliance, and cost negotiation. By efficiently planning and managing the tech transfer process, ensuring regulatory compliance, conducting a comprehensive compliance audit, and effectively negotiating cost-related aspects, Oakley successfully assisted the client in achieving a smooth transition while optimizing commercial production.